JP2006204633A - Patch pharmaceuticals - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide patch pharmaceuticals which is excellent in the handleability at the time of being stuck and less in the possibility of causing an accident by a release sheet after being released. <P>SOLUTION: For the patch pharmaceuticals, the release sheet 1 covering an adhesive material layer is provided with a cut 2 which does not completely divide a single sheet on the sheet, and is kept as a single sheet without being completely divided after being completely released from the adhesive material layer. Preferably, the cut 2 is formed so as to form a sheet part 1A of a small width and a sheet part 1B of a large width, and the sheet part 1A of the small width is arranged along the length of 1/4-1/2 of the outer periphery of the patch pharmaceuticals. Also preferably, the ratio (A:B) of the width (A) of the sheet part 1A of the small width and the width (B) of the sheet part 1B of the large width is 1:2-6, and the ratio (C:D) of the size of the release sheet and the shortest distance (C) from the terminating end of the cut to the outer periphery of the release sheet is 1:3-10. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a patch preparation, and in particular, to a patch preparation having a release sheet.

  In recent years, the development of new medicines requires enormous costs and a great deal of time, and many preparations have been developed that attempt to change the dosage form of existing medicines. One example is a transdermally absorbable preparation. Among them, the types of patch preparations are increasing.

  As a patch preparation, a support, an adhesive layer containing an active ingredient, and a release sheet are generally laminated in this order (so-called “matrix-type patch preparation”). There is also a so-called reservoir type patch preparation having a reservoir holding an active ingredient between the skin adhesive layer (adhesive layer) and the skin adhesive layer (adhesive layer) covered with a release sheet.

  As described above, a patch preparation usually has a pressure-sensitive adhesive layer or skin adhesive layer coated with a release sheet made of a synthetic resin film or silicon processed paper having flexibility for the purpose of protecting the pressure-sensitive adhesive layer or skin adhesive layer. ing. On the other hand, the patch preparation itself (main body) has a flexible support and an adhesive layer for the purpose of reducing physical irritation to the skin, and the patch preparation itself is a soft, soft sheet.

  The functions of the release sheet include, in addition to protecting the adhesive layer, maintaining the shape of a flexible patch preparation, improving operability when applying the patch preparation to the skin, etc. In many cases, a sheet that is more rigid than the laminate of the pressure-sensitive adhesive layer is used as the release sheet.

  In a patch preparation having such a release sheet, it is usually applied to the skin after peeling off the release sheet with a fingertip, nail or the like from a part of its peripheral edge, but since the patch preparation (whole) is a thin sheet, It is difficult to peel off the release sheet, and the time required for the release operation of the release sheet becomes long, and time may be wasted. Therefore, conventionally, in many patch preparations, various devices have been made so that the release work of the release sheet can be easily performed.

  Specifically, (1) a release sheet is provided with a cutting portion, and peeling is performed from the cutting portion (for example, Patent Document 1), (2) a release sheet having a larger area than the plaster is used. (3) A sheet in which two release sheets are overlapped at a substantially central portion of the plaster and peeled from an overlapped portion not contacting the plaster has been proposed.

  Recently, in the patch preparation of the type (1) above, the patch preparation (Patent Document 2) having a release sheet having a shape obtained by cutting the central portion of the sheet into a wavy shape and two cutting lines are provided to divide the sheet into three parts. In addition, a patch preparation (for example, Patent Document 3) that peels off the sheet piece at the center and peels off the release sheets on both sides after application is often seen. However, in this type of adhesive preparation, Since the release sheet is composed of 2 to 3 sheets, a large number of sheets that become dust after the release sheet is peeled off are generated.

By the way, since the patch preparation can change the dose setting of the active ingredient depending on the application area, generally, an application (adhesion) to a child or an infant usually uses a preparation with a reduced area used by an adult. However, when the area is reduced, even if the release sheet is devised as described above, the handling property at the time of sticking tends to be more difficult, and the trouble of the guardian further increases especially when sticking to an infant. For example, if the release sheet is a patch preparation with a central cut, hold the patch preparation with the release sheet on one side in one hand, and hold the infant that does not easily stand still with the other hand. It must be applied and the remaining release sheet must be peeled off, and the operation is complicated. In addition, there are many cases where the patch preparation cannot be applied accurately at the intended location. Accordingly, there is a need for a patch preparation that is easy to handle and can be applied quickly. In addition, in the case of a patch preparation with a small size, the sheet that becomes garbage after peeling becomes even smaller, and multiple pieces of small-sized sheet waste are generated, so in the unlikely event you forget to discard or drop the sheet waste after peeling. If this happens, there is a high possibility that the infant will accidentally swallow the sheet waste.
Japanese Utility Model Publication No. 62-050623 JP-A-10-265372 International Publication No. 00/69422 Pamphlet

  In view of the above circumstances, the problem to be solved by the present invention is to solve various problems associated with conventional patch preparations having a release sheet, good operability at the time of sticking, and peeling after peeling It is to provide a patch preparation that can reduce the possibility of an accident caused by a sheet.

As a result of intensive studies to solve the above problems, the present inventor has completed the present invention having the following configuration.
That is, the present invention
(1) The release sheet that covers the pressure-sensitive adhesive layer is a single sheet provided with a cut that does not completely divide the sheet. A patch preparation, characterized in that it remains a single sheet,
(2) A notch is formed in a single sheet so that a sheet portion having a small width and a sheet portion having a large width are formed at the boundary of the notch. The patch preparation according to (1) above, which is disposed along a length of / 4 to 1/2,
(3) The ratio (A: B) of the width (A) of the small sheet portion to the width (B) of the large sheet portion is 1: 2 to 6 and the size of the release sheet (D ) And the shortest distance (C) from the end of the cut to the outer periphery of the release sheet (C: D) is 1: 3 to 10, the patch preparation according to (2) above,
(4) The patch preparation according to any one of (1) to (3) above, wherein the cut is formed so as to run substantially parallel to the outer periphery of the patch preparation,
(5) The patch preparation according to any one of the above (1) to (4), wherein a single sheet is subjected to a treatment that enables bending at a straight portion in contact with the cut.
(6) The patch preparation according to the above (5), wherein the treatment that allows bending at a straight part in contact with the cut is a part of the sheet,
(7) The patch preparation according to (5) above, wherein the treatment that enables bending at a straight portion in contact with the cut is a half-cut treatment for the thickness of the sheet,
(8) The adhesive preparation according to any one of (5) to (7) above, wherein the crossing angle (R) between the notch and the linear part in contact with the notch is 0 to 90 °,
(9) The patch preparation according to any one of (1) to (8) above, wherein the planar shape is a substantially square patch preparation, and the length of one side of the substantially square shape is 10 to 50 mm. Patch preparation,
(10) The patch preparation according to any one of the above (1) to (8), wherein the patch is a patch or patch having a circular or elliptical shape, and the diameter or major axis of the circle or ellipse is 10 to 50 mm. And (11) The adhesive preparation according to any one of (1) to (10) above, wherein the release sheet has a thickness of 30 to 150 μm.

  According to the patch preparation of the present invention, a part of the release sheet is peeled off, and the adhesive preparation layer can be temporarily attached by sticking the exposed adhesive layer to the skin by holding the peeled part by hand. Is completely peeled off and the exposed part of the remaining pressure-sensitive adhesive layer is applied to the skin, so that the patch preparation can be applied to the intended part of the skin with one hand relatively easily. Therefore, for example, when applying a patch preparation to an affected area such as an infant who does not easily stand still, quickly apply the patch preparation to the affected area of the infant while holding the infant with one hand. Can do. Furthermore, since the release sheet completely peeled off from the pressure-sensitive adhesive layer remains a single sheet, even if it is a small-sized patch preparation, there is no generation of micro-size sheet waste after peeling off the release sheet. It is possible to prevent an accident that an infant accidentally swallows sheet waste.

Hereinafter, the present invention will be described in more detail.
1 and 2 are plan views of first and second specific examples of the patch preparation of the present invention as seen from the release sheet side. As shown in the patch preparations 10 and 20 of the first and second specific examples, the patch preparation of the present invention completely separates the release sheet 1 covering the adhesive layer into a single sheet. The main feature is that the notch 2 is provided, and preferably, the notch 2 is divided into a single sheet 1 with a small width 1A and a wide width sheet 1B with the notch 2 as a boundary. And are formed so as to be formed. Here, the release sheet 1 maintains the state of a single sheet without being completely divided even after completely peeling from the pressure-sensitive adhesive layer, as will be described below.

3 (a) to 3 (d) are diagrams schematically showing the procedure of the pasting operation of the medicated patch 20 shown in FIG. 2, in which the same reference numerals as those in FIG. 2 indicate the same or corresponding parts. Reference numeral 4 denotes a support.
The sticking method of the patch preparation of the present invention will be described with reference to FIG. 3. First, the sheet part 1 B on the larger side of the two sheet parts 1 A and 1 B divided by the notch 2 of the release sheet 1. Is peeled off (FIGS. 3A and 3B).
Next, the peeled sheet part 1B is held by hand (not shown), and the adhesive surface 3a (FIG. 3B) of the adhesive layer 3 exposed by peeling of the sheet part 1B is desired on the skin surface. Affixed to the part (affected part) (not shown) (FIG. 3 (c)), and then the sheet part 1B is pulled around the adhesive preparation 20 to completely remove the release sheet 1 from the adhesive layer 3 (Fig. 3 (d)), and the entire adhesive surface 3a of the adhesive layer 3 is pressure-bonded to the skin (affected part) (not shown). Note that the release sheet 1 completely peeled off from the pressure-sensitive adhesive layer 3 is not divided into two or more sheet pieces as shown in FIG. Remains.

  Thus, in the adhesive preparation of the present invention, the sheet portion 1B having a large width of the release sheet 1 is peeled off, and the adhesive layer 3 exposed by holding the peeled sheet portion 1B with one hand is attached to the skin, By pulling the sheet portion 1B around, the release sheet 1 can be completely peeled off from the pressure-sensitive adhesive layer 3, and the entire pressure-sensitive adhesive surface of the pressure-sensitive adhesive layer 3 can be pressure-bonded to the skin. Can be applied to the intended part of the skin. Further, the release sheet 1 completely peeled off from the pressure-sensitive adhesive layer 3 is a single sheet as shown in FIG. 3 (d). When configured, since a plurality of minute sheet scraps are not generated, it is possible to prevent an accident that an infant or the like accidentally swallows the release sheet after the release.

  In the patch preparation of the present invention, examples of the release sheet include a plastic sheet subjected to a release treatment, a metal foil, and silicon processed paper. Preferably, a known release treatment (for example, silicone release treatment, etc.) on unstretched or stretched polypropylene, polyethylene terephthalate, polyethylene, polyvinyl chloride, polyester, polyvinylidene chloride, polystyrene or other films or sheets, or aluminum foil And silicon processed paper.

  Moreover, 30-150 micrometers is preferable and, as for the thickness of a peeling sheet, 50-100 micrometers is more preferable. As will be described later, in the sticking operation (work) of the patch preparation of the present invention, it is preferable to perform a work of bending the release sheet 1 after peeling a part of the release sheet 1 (the sheet portion 1B having a large width). If the release sheet 1 is too thick, it is difficult to bend, and if the release sheet 1 is too thin, a part of the release sheet 1 (the sheet portion 1B having a large width) is peeled off, and then the part (width). This is because it is difficult to carry out the pasting operation by holding the large sheet portion 1B) by hand.

  The medicated patch of the present invention has a basic structure in which an adhesive layer and a release sheet covering the adhesive layer are laminated on at least one surface of a support. The pressure-sensitive adhesive of the pressure-sensitive adhesive layer 3 is not particularly limited as long as it is a pressure-sensitive adhesive for medical use without skin irritation, and is an acrylic pressure-sensitive adhesive, natural rubber-based pressure-sensitive adhesive, synthetic rubber-based pressure-sensitive adhesive, vinyl ether-based pressure-sensitive adhesive, A silicone-based pressure-sensitive adhesive or the like can be used. The adhesive layer 3 can hold any drug as long as it is held in a dissolved state, a dispersed state, or a crystal precipitation state and can express systemic or local medicinal effects transcutaneously. Specific examples of such drugs include corticosteroids, analgesic / anti-inflammatory agents, hypnotic sedatives, tranquilizers, antihypertensive agents, antihypertensive diuretics, antibiotics, general anesthetics, antibacterial agents, and antifungal agents. Vitamins, coronary vasodilators, antihistamines, antitussives, sex hormones, antiepileptics, cerebral circulation improving agents, antiemetics, antitumor agents, biopharmaceuticals, narcotics and the like. Two or more kinds of these drugs may be used in combination as necessary. At that time, it is also possible to add an appropriate amount of a known absorption promoter or cross-linking agent for a transdermal drug. Furthermore, a reservoir holding an active ingredient is provided between the support and the pressure-sensitive adhesive layer (skin adhesive layer), and a so-called reservoir-type patch preparation in which the pressure-sensitive adhesive layer (skin adhesive layer) is covered with a release sheet is provided. Is also possible. In the present invention, the thickness of the pressure-sensitive adhesive layer 3 is generally 10 to 200 μm, preferably 20 to 160 μm.

  The support 4 used in the patch preparation of the present invention is preferably one in which safety is ensured, and the support is thin so that there is little physical irritation due to the edge portion of the support when sticking. It is preferable. Specific examples of such a support include polyester, nylon, saran, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyvinyl chloride, ethylene-ethyl acrylate copolymer, polytetrafluoroethylene, surrin. A single film such as a metal foil and a laminate film thereof are suitable. Nonwoven fabrics, woven fabrics, knitted fabrics, non-porous sheets, perforated sheets, and the like made of the above materials are also suitable, and a support formed as a laminate sheet by any combination thereof may be used. Although the thickness of a support body is not specifically limited, Generally, it is 2-150 micrometers, Preferably it is 5-100 micrometers.

  In the patch preparation of the present invention, the planar shape of the patch preparation is not particularly limited, but from the viewpoints of ease of peeling work of the release sheet, ease of sticking operation of the patch preparation, and the like in FIGS. A substantially rectangular shape such as the patch preparations 10 and 20 and a circular or elliptical shape such as the patch preparations 30 and 40 shown in FIGS. 4 and 5 are preferable. 4 and 5 are plan views of the third and fourth specific examples of the patch preparation of the present invention as viewed from the release sheet side. In the present invention, the “substantially square” in the planar shape of the patch preparation means a substantially square, a substantially rectangular, a rhombus, a trapezoid and the like. Among these, from the viewpoint of reduction of physical stimulation due to the edge of the support and ease of peeling work, the squares and rectangles shown in FIGS. 1 and 2 (for example, squares, rectangles, rounded corners thereof) The shape provided is preferable. Further, the “substantially square” is a concept including a shape with rounded corners as shown in FIGS. 1 and 2. The “corner portion” is a concept including not only a tip portion formed by joining two sides in a substantially square shape but also an arc portion when the tip portion is rounded.

  In the present invention, when the patch preparation is a patch preparation having a substantially square planar shape, the four corners may be provided with arc portions having appropriate curvature radii as shown in FIGS. The curvature radius is preferably 1 to 7 mm. When the radius of curvature is less than 1 mm, there is no significant difference from the case where the radius is not rounded, so it makes little sense to form an arc, and when it exceeds 7 mm, there is no significance in terms of formulation characteristics, and the production yield is reduced and the economy is reduced. Tend to be disadvantageous.

  In the patch preparation of the present invention, the cut 2 formed in the release sheet 1 is basically formed so as to run substantially parallel to the outer periphery of the patch preparation as shown in FIGS. The cut shape may be a straight line or a curved line, and may be a wavy line as shown in FIG. The wavy line is preferable in terms of facilitating peeling of the release sheet. In addition, the notch 2 may have an irregular shape as shown in FIGS. 7 and 8 as long as the narrow sheet portion 1A and the wide sheet portion 1B are formed on the single sheet 1. It may be. However, in such a case, the release sheet 1 is completely removed from the pressure-sensitive adhesive layer after the pressure-sensitive adhesive layer is attached to a desired portion (affected part) (not shown) of the skin surface with the sheet portion 1B on the wide side. The peelability at the time of peeling may be slightly lowered. In addition, the code | symbol L2 in FIGS. 6-8 is a planned bending line demonstrated later.

  In the patch preparation of the present invention, the “width” in the “small sheet portion” and the “large sheet portion” is the width in the direction perpendicular to the notch 2 (the outer periphery of the sheet in the direction perpendicular to the notch from the notch). In FIG. 1, 2, 4 and 5, the symbol A is the width of the sheet portion 1A having a small width, and the symbol B is the width of the sheet portion 1B having a large width. The ratio (A: B) of the width (A) of the sheet portion 1A having a small width and the width (B) of the sheet portion 1B having a large width varies depending on the shape of the cut 2, the planar shape of the patch preparation, etc. In particular, the ratio is suitably 1: 2-6, preferably 1: 3-6. In the case of a patch preparation having a substantially square planar shape, the “width” in the “small sheet portion” and the “large sheet portion” at the position along the substantially square “corner” of the notch 2 is the above. The “width” in the vicinity of the start position of the notch 2 may also be out of the above dimensional ratio.

  When the sheet portion 1B having a large width as an operation piece when peeling the release sheet 1 is bent from the base (FIG. 3 (b)), it may have a size that protrudes from the outer periphery of the patch preparation. Although preferable from the viewpoint of the operability of the sticking operation, if the end portion 2x of the cut 2 (reference numeral 2x in FIGS. 1, 2, 4 and 5) is too close to the outer periphery of the release sheet 1, the sheet portion 1B which is an operation piece When the sheet part 1B is peeled off or when the sheet part 1B is bent from its base, not only the sheet part 1B but also the peripheral part (adhesion (adhesion to the peripheral part of the adhesive layer 3) connected to the sheet part 1B of the release sheet 1 ) Is peeled off, and the subsequent sticking operation becomes difficult. Therefore, the ratio (C: D) of the size (D) of the release sheet and the shortest distance (C) from the terminal end 2x of the cut 2 to the outer periphery of the release sheet is preferably 1: 2 to 6, It is more preferable that it is 1: 3-7.

  In the present invention, “the shortest distance (C) from the end portion of the cut to the outer periphery of the release sheet” refers to a straight line (in FIG. 1, 2, 4 and 5) that is the shortest from the end portion 2x of the cut 2 to the outer periphery. The length of the straight line L1). Further, the “size (D) of the release sheet” means that the straight line parallel to the straight line L1 is overlapped on the straight line L1 and drawn so as to intersect the outer periphery of the release sheet at two points. It is the distance (length) between two points. In FIGS. 1, 2, 4, and 5, a straight line parallel to the straight line L1 is omitted.

  In the patch preparation of the present invention, the notch 2 formed in the release sheet 1 has a sheet portion 1A having a small width defined by the notch 2 that is 1/4 to less than the outer periphery of the patch preparation, as shown in FIGS. It is preferably formed so as to be arranged along a half length (part). When the length of the cut 2 is shorter than this (that is, when the sheet portion 1A having a small width is only along a length (part) less than ¼ of the outer periphery of the patch preparation), wrinkles are caused by the flexibility of the patch preparation. However, when the length is longer than this (ie, the sheet portion 1A having a small width is longer than 1/2 of the outer periphery of the patch preparation). (In the case of (part)), holding the peeled sheet part 1B (operation piece), sticking the adhesive surface to the skin, and peeling off the peeling sheet when the remaining part (including the sheet part 1A) is peeled off. Tend to be.

  In the patch preparation of the present invention, first, the sheet part 1B having a large width is peeled off, the sheet part 1B is bent from its root, and the sheet part 1B is used as an operation piece to perform the sticking operation. For this reason, it is preferable to preliminarily define a planned bending line (straight line) that allows the sheet to be bent in the vicinity of the base of the sheet portion 1B of the release sheet 1 so as to contact the notch 2. As a treatment for defining (straight line), a treatment for giving a linear crease by printing or the like, a treatment for cutting a part of a sheet (for example, 1 to 2 mm for portions to be applied to both ends of a planned bending line) The cut | interruption of the length of a grade is formed.) The process etc. which perform a half cut in the thickness direction of a sheet | seat are mentioned. In addition, as a method of cutting a part of the sheet or performing a half cut in the thickness direction of the sheet, it is preferable to perform by laser cutting, and if it is a laser cutting apparatus, the adhesive layer can be controlled by controlling irradiation energy and irradiation time. Is not affected, and only the release sheet can be cut.

  FIGS. 9A to 9C show various modes of the planned bending line L2 formed on the release sheet 1 of the patch preparation 10 having a substantially square planar shape shown in FIG. 10 is an embodiment of the planned bending line L2 formed on the release sheet 1 of the patch preparation 30 having a circular planar shape shown in FIG. 4, and FIG. 11 is a patch preparation 40 having an elliptical planar shape shown in FIG. The one aspect | mode of the bending expected line L2 formed in this peeling sheet is shown. As shown in these drawings, in the present invention, the crossing angle (R) between the notch 2 (extension line thereof) and the planned bending line L2 in contact with the notch is preferably in the range of 0 to 90 °. The range of 0 to 60 ° is more preferable. Further, the planned bending line L2 may be in contact with the notch 2 in the vicinity of the end portion 2x of the notch 2, and may be formed so as to be in direct contact with the end portion 2x of the notch 2 (FIGS. 9A and 9B). 2 may be formed so as to be in contact with each other in the vicinity of the end portion 2x (FIG. 9C). When the crossing angle (R) between the notch 2 and the planned bending line L2 in contact with the notch is larger than 90 °, it is not preferable because the sheet portion 1A cannot be easily peeled even if the peeled sheet portion 1B is held. In the present invention, the planned bending line L2 is formed so as to overlap the straight line L1 corresponding to the virtual cut when the above-described cut 2 is continuously formed in the direction without being terminated at the terminal end 2x. The sheet is formed on the side of the large sheet portion 1B with respect to the straight line L1.

  The size (size in plan view) of the patch preparation of the present invention is not particularly limited, but the configuration of the release sheet in the patch preparation of the present invention is a particularly effective means for a patch preparation having a relatively small size. In other words, in a small-sized patch preparation having a release sheet that is completely divided into two or more conventional sheet pieces, the release sheet (sheet waste) that becomes trash after the release sheet is removed has a plurality of smaller sizes. It becomes a sheet piece (usually the sheet piece is flat), and its disposal work is complicated. For example, when a peeled release sheet is placed on a flat surface such as a table, it is difficult to pick up the sheet in a flat shape with a small size. On the other hand, the release sheet of the patch preparation of the present invention is a single product (holding one continuous state) even after release, and has a three-dimensional shape partially standing up by bending. Therefore, even when a peeled release sheet is placed on a flat surface such as a table, it can be easily picked up and can be promptly discarded. Therefore, the patch preparation of the present invention is, for example, a patch preparation in which the length of one side of the substantially square is 10 to 50 mm when the planar shape is a substantially square patch preparation, or the planar shape is circular or elliptical. The effect is more markedly exhibited in a patch preparation having a relatively small size, such as a patch preparation having a circular or elliptical diameter or major axis in the range of 10 to 50 mm in the case of a patch preparation.

  The method for producing the patch preparation of the present invention can be produced by a conventionally known method. For example, on the release sheet 1 whose surface has been subjected to a release treatment, the adhesive solution is applied so that the adhesive layer 3 having a desired thickness is formed, and after removing the solvent, the support 4 is bonded together, A sheet-shaped original fabric (laminated body) is prepared, and a patch preparation having a desired planar shape is punched (extracted) from the sheet-shaped original fabric (laminate), and a cut 2 is formed in the release sheet 1 simultaneously with the punching (extracting). Alternatively, the punch preparation of the present invention can be produced by forming a cut 2 with a metal blade or the like in the release sheet 1 of the patch preparation after the punching (pull-out). A die cutting or a laser cutting device can be used as the punching device, but when the cut 2 is formed in the release sheet 1 in the same process as the punching, it is preferable to use a laser cutting device. If a laser cutting device is used, a preparation having an arbitrary shape can be easily pulled out, and the cut 2 is formed in the release sheet 1 without affecting the adhesive layer by controlling the irradiation energy and irradiation time. be able to.

  The patch preparation of the present invention can be applied to the surface of skin, mucous membrane, etc., and can be widely applied to medical or hygiene materials, taping and the like.

  EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples. However, the present invention is not limited to the examples described below.

Example 1
A polyethylene terephthalate (PET) film having a thickness of 75 μm, which has been subjected to silicone release treatment, is coated with an ethyl acetate solution of an acrylic acid / octyl acrylate ester copolymer so that the thickness after drying is 40 μm. The nonwoven fabric surface of a support obtained by laminating a PET film to a polyethylene terephthalate nonwoven fabric having an amount of 12 g / m ² was bonded to obtain a sheet-shaped original fabric. Next, the sheet-shaped original fabric is laser-cut, and a sheet body having an approximately square shape with a side of 15 mm with four corners rounded from the sheet-shaped original fabric is extracted. A position (a position on one side adjacent to the corner) that is 3 mm away from the apex of the corner when any one of the four corners of the square sheet is not rounded. As shown in FIG. 1 (FIG. 9), a release sheet (polyethylene terephthalate film) is formed with a straight cut (length 12 mm) parallel to one side of a substantially square, and further a half cut for defining a planned bending line The treatment was applied in a straight line to form the planned bending line shown in FIG.
That is, the patch preparation I corresponding to FIG. 9A (intersection angle between the cut 2 and the planned bending line L2: 90 °), and the patch preparation II corresponding to FIG. 9B (intersection of the cut 2 and the planned bending line L2). (Angle: 45 °) and patch preparation III corresponding to FIG. 9 (c) (length of planned bending line L2: 8 mm, crossing angle of cut 2 and planned bending line L2: 45 °) were prepared.

(Example 2)
From the sheet-like raw material obtained in Example 1, by the same process as in Example 1, the same four corners as in Example 1 are rounded with a radius of curvature of 3 mm, and a substantially square sheet with a side of 30 mm. Was cut out, and cuts and planned bending lines shown in FIG. 12 were formed in the extracted sheet body.
That is, patch preparation IV corresponding to FIG. 12 (a) (start point of cut 2: position 5 mm from the apex of the corner, 5 mm distance between cut 2 and one side of the square, depth of cut 2: 5 mm, cut 2 And the planned bending line L2 crossing angle: 0 °, the length of the bending planned line L2: 7 mm), patch preparation V corresponding to FIG. 12B (starting point of the cut 2: 5 mm from the corner apex, cut) 12 and a side of a substantially square 5 mm, the depth of the notch 2 is 5 mm, the crossing angle between the notch 2 and the planned bending line L2 is 0 °, and the length of the planned bending line L2 is 23 mm), FIG. Corresponding patch preparation VI (starting point of notch 2: middle of one side of approximately square, interval 5 mm between notch 2 and one side of approximately square, depth of notch 2: 5 mm, angle of intersection of notch 2 and expected bending line L2: 0 °, the length of the planned bending line L2: 7 mm).

(Example 3)
A circular sheet having a diameter of 30 mm was extracted from the sheet-shaped raw material obtained in Example 1 by the same process as in Example 1, and the cuts and planned bending lines shown in FIG. 10 were formed in the extracted sheet. That is, the patch preparation VII corresponding to FIG. 10 (the interval between the notch 2 and the outer periphery of the circular patch preparation is 5 mm, the depth of the notch 2 is 5 mm, the crossing angle between the notch 2 and the expected bending line L2 is 0 °, the expected bending line L2 The length was 13 mm).

Example 4
From the sheet-shaped raw material obtained in Example 1, an elliptical sheet body having a major axis of 45 mm and a minor axis of 30 mm is extracted by the same processing as in Example 1, and the notch shown in FIG. A planned bending line was formed. That is, the patch preparation VIII corresponding to FIG. 10 (the interval between the notch 2 and the outer periphery of the oval patch preparation is 5 mm, the depth of the notch 2 is 5 mm, the crossing angle between the notch 2 and the planned bending line L2 is 30 °, the planned bending line) L2 length was 10 mm).

(Comparative Example 1)
From the sheet-shaped raw material obtained in Example 1, in the same manner as in Example 1, a substantially square-shaped sheet body having a side with a radius of 2 mm and four corners similar to those in Example 1 with a side of 15 mm. As shown in FIG. 13, a linear cutting line 12 that divides the release sheet 1 into two equal parts is formed at the center of the release sheet 1 of the extracted sheet body, and a patch preparation (Patch preparation IX )

  The adhesive preparations I to IX prepared in Examples 1 to 4 and Comparative Example 1 were evaluated by 10 adults, and the patient's own chest was subjected to a sticking operation. did. The average value of 10 evaluation points in each item was determined, and the results are shown in Table 1.

(Operability after peeling off the first separator)
3 points: The pressure-sensitive adhesive surface and the separator are not attached, and the operation with one hand is easy.
2 points: The pressure-sensitive adhesive surface and the separator are likely to stick, and the operation with one hand is somewhat difficult.
1 point: The pressure-sensitive adhesive surface and the separator partially stick together, and the operation with one hand is quite difficult.
0 point: The pressure-sensitive adhesive surface and the separator stick to each other, and the pasting operation cannot be continued.

(Ease of sticking and ease of removing the remaining separator)
3 points: A part of the pressure-sensitive adhesive surface can be easily attached to the affected part by holding it with one hand, and the remaining separators can be peeled off smoothly.
Two points: A part of the pressure-sensitive adhesive surface can be attached to the affected part by grasping with one hand, and the remaining separator can be peeled off.
1 point: It is difficult to attach a part of the adhesive surface to the affected area by holding it with one hand, but the remaining separator can be peeled off.
0 point: It is difficult to apply a part of the adhesive to the affected part by holding it with one hand, and the remaining separator cannot be peeled off.

(Attached state)
3 points: Can be applied well without wrinkles.
2 points: Slight wrinkles but can be applied almost satisfactorily.
1 point: Wrinkles enter considerably and cannot be applied well.
0 point: Cannot be applied.

(Overall operability)
3 points: Very easy to operate.
2 points: Easy to operate.
1 point: Slightly difficult to operate.
0 point: difficult to operate.

  From the above results, the adhesive preparations I to VIII of Examples 1 to 4 have excellent handleability at the time of application, and can be operated with one hand without inadvertently attaching the adhesive surface and the separator particularly during the application operation. Further, it was confirmed that the separator can be peeled off very smoothly, and a series of pasting operability is improved and improved.

It is the top view which looked at the 1st specific example of the patch preparation of this invention from the release sheet side. It is the top view which looked at the 2nd specific example of the medicated patch of this invention from the release sheet side. Drawing (a)-figure (d) are the figures showing typically the procedure of the sticking operation of the patch preparation shown in FIG. It is the top view which looked at the 3rd example of the medicated patch of this invention from the release sheet side. It is the top view which looked at the 4th specific example of the medicated patch of this invention from the release sheet side. It is a figure which shows the variation of the notch | incision and bending plan line which are provided in the peeling sheet in the adhesive preparation of this invention. It is a figure which shows the variation of the notch | incision and bending plan line which are provided in the peeling sheet in the adhesive preparation of this invention. It is a figure which shows the variation of the notch | incision and bending plan line which are provided in the peeling sheet in the adhesive preparation of this invention. Drawing (a)-figure (c) are figures showing the variation of the bending line provided in the exfoliation sheet in the patch preparation shown in FIG. It is a figure which shows an example of the bending plan line provided in the peeling sheet in the adhesive preparation shown in FIG. It is a figure which shows an example of the bending expected line provided in the peeling sheet in the adhesive preparation shown in FIG. It is a figure which shows the variation of the notch | incision and bending plan line which are provided in the peeling sheet in the adhesive preparation of this invention. It is the top view which looked at the patch preparation of the comparative example 1 from the release sheet side.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Release sheet 1A Small sheet part 1B Large sheet part 2 Incision 2x Termination part of incision 3 Adhesive layer 4 Support body 10, 20, 30, 40 Patch preparation

Claims (11)

  The release sheet covering the pressure-sensitive adhesive layer is a single sheet provided with cuts that do not completely divide the sheet, and even after the release from the pressure-sensitive adhesive layer completely, the single sheet A patch preparation characterized by remaining.   A notch is formed in a single sheet so that a narrow sheet portion and a wide sheet portion are formed at the border of the notch, and the narrow sheet portion is 1/4 to the outer periphery of the patch preparation. The adhesive preparation according to claim 1, which is arranged along a length of ½.   The ratio (A: B) of the width (A) of the small sheet portion to the width (B) of the large sheet portion is 1: 2 to 6, and the size (D) of the release sheet and the notch The patch preparation according to claim 2, wherein the ratio (C: D) to the shortest distance (C) from the terminal end to the outer periphery of the release sheet is 1: 3-10.   The patch preparation according to any one of claims 1 to 3, wherein the cut is formed so as to run substantially parallel to the outer periphery of the patch preparation.   The patch preparation according to any one of claims 1 to 4, wherein the single sheet is subjected to a treatment that enables bending at a straight portion in contact with the cut.   The patch preparation according to claim 5, wherein the treatment that enables bending at a straight portion in contact with the cut is a part of the sheet.   The patch preparation according to claim 5, wherein the treatment that enables bending at a straight portion in contact with the cut is a half-cut treatment with respect to the thickness of the sheet.   The patch preparation according to any one of claims 5 to 7, wherein the crossing angle (R) between the notch and the straight part in contact with the notch is 0 to 90 °.   The patch preparation according to any one of claims 1 to 8, wherein the patch preparation is a substantially square patch and the length of one side of the rectangle is 10 to 50 mm.   The patch preparation according to any one of claims 1 to 8, wherein the patch preparation has a circular or oval planar shape, and the diameter or major axis of the circle or ellipse is 10 to 50 mm.   The adhesive preparation according to any one of claims 1 to 10, wherein the release sheet has a thickness of 30 to 150 µm.

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